BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3954879 · Received July 16, 2014

    Report

    Report Number
    1627487-2014-08123
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    July 1, 2012
    Report Date
    June 27, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S SCS SYSTEM IS INOPERABLE AND HAS NOT BEEN CHARGED OR USED IN THE PAST TWO YEARS. COMMUNICATION COULD NOT BE ESTABLISHED BETWEEN SCS IPG AND EXTERNAL DEVICES. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416001 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 50408

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other SCS LEAD: MODEL 4156 (X2)| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3146| SCS EXTENSION: MODEL 3341